Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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pharmaphorum

NOVEMBER 23, 2021

Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. Sanofi is the first pharma company to partner with Baidu on its LinearDesign AI platform, which has been developed specifically to optimise the sequence of mRNA-based vaccines and drugs.

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Pharmaceutical Technology

MAY 16, 2023

Bavarian Nordic has completed the acquisition of Emergent BioSolutions ’ travel vaccine portfolio for an upfront payment of $274m, with the potential for the total value to rise to $384m. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

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STAT News

AUGUST 9, 2022

heath secretary recently declared monkeypox as a public health emergency , paving the way for emergency use authorizations of additional vaccines or vaccine regimens to fight the disease. The same day, Food and Drug Administration Commissioner Robert Califf said that the U.S. — by changing the way it is given.

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Vaccination Vaccine Licensing Licensing 105

World of DTC Marketing

FEBRUARY 11, 2022

Pfizer has held a vaccine monopoly, blocking low-income countries from accessing its novel technology, while enriching shareholders at levels advocates for vaccine equity label “obscene.” Sure they developed a vaccine but isn’t it a moral responsibility to share it with the world? The Atlantic ). How much profit is enough?

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Vaccination Vaccine Sales Licensing 212

BioPharma Reporter

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted Pfizerâs Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV in infants.

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Vaccination Vaccine Licensing Licensing 98

Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

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BioPharma Reporter

JULY 19, 2021

The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTechâs COVID-19 vaccine Biologics License Application (BLA).

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Vaccination Vaccine Licensing Licensing 98

BioPharma Reporter

DECEMBER 8, 2022

The US Food and Drug Administration (FDA) has accepted Pfizerâs RSV vaccine Biologics License Application (BLA) for priority review: with a decision expected in May.

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Vaccination Vaccine Licensing Licensing 98

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. 5-adapted bivalent vaccine.

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Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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Pharmaceutical Technology

MAY 15, 2023

Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023. Moderna and Johnson & Johnson are also at Phase III trial stages for respective mRNA and recombinant vector vaccines.

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Pharmaceutical Technology

AUGUST 1, 2022

Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities. The shift from private to public funding enabled more rapid development of Covid-19 drugs and vaccines.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Trials Clinical Trials Clinical Trials Licensing 264

Outsourcing Pharma

NOVEMBER 16, 2021

The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.

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BioPharma Reporter

DECEMBER 6, 2021

Australiaâs Noxopharm has in-licensed novel RNA tech developed by Hudson Institute of Medical Research: focusing on RNA drug discovery and mRNA vaccine manufacture via Noxopharmâs subsidiary Pharmorage.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

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pharmaphorum

OCTOBER 7, 2021

Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. of Africans have been fully vaccinated against COVID-19, and just 15 African nations have met the agency’s objective of 10% coverage.

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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pharmaphorum

DECEMBER 6, 2022

Pfizer and partner BioNTech have launched a countersuit against Moderna in a patent despite centring on their mRNA-based vaccines for COVID-19. It also waived its rights to bring the lawsuit when it pledged not to sure other COVID-19 vaccine producers during the pandemic, according to Reuters.

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XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

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XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work?

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XTalks

DECEMBER 20, 2021

The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.

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Vaccination Vaccine Protein Manufacturing 96

Pharmaceutical Commerce

DECEMBER 19, 2023

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

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pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . of individuals in low-income countries have received their first dose.

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XTalks

NOVEMBER 29, 2021

Pfizer and vaccine partner BioNTech shared positive long-term data last week that shows their COVID-19 vaccine remains effective for at least four months in adolescents 12 to 15 years of age. The vaccine also maintained a good safety profile with no serious side effects.

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XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. The efficacy against severe MA-LRTI was 81.8

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Vaccination Vaccine Clinical Trials Clinical Trials 97

pharmaphorum

SEPTEMBER 3, 2021

Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. At its recent business update, GSK said it was anticipating peak sales of more than $4 billion for its vaccine if approved.

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BioSpace

JANUARY 12, 2021

Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review. Merck announced the U.S.

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pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

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XTalks

DECEMBER 2, 2020

British officials have granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine, making it the first approved vaccine in the world for the novel coronavirus. Related: Pfizer and BioNTech Complete Phase III Analysis of COVID-19 Vaccine, Revealing it is 95 Percent Effective.

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Pharmaceutical Technology

OCTOBER 19, 2022

Eucure will oversee the production and delivery of the drug, while Syncromune will handle the clinical development and marketing. Syncromune president and CEO Eamonn Hobbs said: “We are excited to enter into an exclusive licensing agreement with Eucure/Biocytogen.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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